RP G28 fails to meet endpoints in its LIBERATUS phase III trial to treat lactose intolerance

Ritter Pharmaceuticals, Inc.announced that its Phase III clinical trial of RP G28 for lactose intolerance (LI) failed to demonstrate statistical significance in its pre-specified primary endpoint. Top-line data from the 557-subject Phase III clinical trial indicates that RP G28 provided significant symptom improvement in patients; however, there was no or little difference compared to placebo.

In the primary endpoint, measuring LI symptom reduction at day 61 (30 days post-treatment) compared to baseline, the treatment group reported a 3.159 mean reduction compared to a reported 3.420 mean reduction in the placebo group (p-value, one-sided = 0.106). Additionally, RP G28 missed its first secondary endpoint of responders with a meaningful treatment benefit: 36.2% of treatment group compared to 34.1% of placebo group (p-value, one-sided= 0.284). The remaining secondary endpoints also missed statistical significance differences with treatment and placebo generally reporting similar results to each other. RP G28 was generally well-tolerated, with placebo and treatment groups reporting similar safety profiles.